Advance Care Planning & Goals of Care Randomized Controlled Trial in Primary Care

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McMaster University

Status

Completed

Conditions

Chronic Illness
Comorbidities

Treatments

Other: Usual care
Behavioral: ACP Education

Study type

Interventional

Funder types

Other

Identifiers

NCT03434626
06-17

Details and patient eligibility

About

Sometimes people with health conditions become ill suddenly and can no longer speak for themselves and another person (such as a family member) will make health care decisions for them. This means it is important for people to think about their wishes and tell others about them. This is called advance care planning. When people have done advance care planning, if they become very sick and cannot speak for themselves they are more likely to get the kind of health care they want and it is easier for the people who make decisions for them. In Alberta, there is a form in the health care system that is used to indicate a person's wishes if participants are unable to speak for themselves. There are tools such as brochures, questionnaires, and videos that can help participants learn about advance care planning and serious illness conversations. This research is being done to study whether using tools for advance care planning will help improve goals of care designation completion rates in such a way that they better reflect patient values. In this project, we aim to determine the efficacy of tools to increase the quality and quantity of advance care planning (ACP) and Goals of Care Determinations (GCD) in primary care settings in Alberta.

Full description

In prospective and randomized trials, advance care planning (ACP) significantly improves outcomes including increased likelihood that clinicians and families understand and comply with a patient's wishes, reduces hospitalization at the end of life, results in less intensive treatments at the end of life (according to patients' wishes) and increases use of hospice services. Trials have not been done in primary care. The aim of this study is to determine the efficacy of a care pathway designed to increase the quality and quantity of ACP in patients and their substitute decision-makers in primary care. The study is a multi-site, patient-based, unblinded, randomized trial conducted in family practices in Canada. Participants will be patients who are determined by their physician to be able to benefit from ACP, and the patient's substitute decision-maker. Participant pairs will be randomized to immediate intervention (care pathway) or delayed (8-12 weeks). The intervention is guided use of tools and decision aids to clarify values and preferences for treatments in the event of serious illness or near end of life. The outcomes will be presence of a goals of care form in the chart, substitute decision-maker engagement in ACP (including self-efficacy for enacting the role), patient engagement in ACP, and decisional conflict.

Enrollment

120 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • age 65 years or older
  • have at least one chronic condition that may be life-limiting

Exclusion criteria

Unable to communicate with an English-speaking research coordinator

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

ACP Education
Experimental group
Description:
Eligible patients in the experimental group will receive an educational intervention from an advance care planning navigator consisting of a 4-item values tool, a Goals of Care Designation form and, if applicable, watch a cardiopulmonary resuscitation video.
Treatment:
Behavioral: ACP Education
Other: Usual care
Usual care
Active Comparator group
Description:
Patients in the usual care group will complete a Goals of Care Designation form with the family physician.
Treatment:
Other: Usual care

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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